QA Validation Specialist
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Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cold Room/Freezers -22degreesF/-6degrees C Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
Reports To: QA Validation Manager
Group/Division: Pharma Services Group/Clinical Trials Division
Position Location: Horsham
Number of Direct Reports: 0
Position Summary
As a QA Validation Specialist you will be responsible for interacting with various departments to provide validation support to validate equipment equipment systems and computer systems along with the critical utilities and facilities required for operations at the Horsham & Crawley Sites.
You will work as part of the QA Validation team to establish engineering specifications and requirements for implementation and procurement of commercial equipment. You will be responsible for ensuring site compliance and all vital activities are performed on time to keep all site validated systems in a validated state.
Key Responsibilities:
- To lead coordinate perform author and support validation/qualifications reviews and change control activities including equipment facilities systems cleaning distribution and CSV
- To agree scope of validation/qualification activities in line with company and regulatory requirements
- Work closely with engineering and operations to write and perform qualification and validation documents including URS SIA VP DQ ) Factory Acceptance Testing (FAT requiring some travel) Site Acceptance Testing (SAT) IQ OQ PQ CSV PV and VSR
- Provide support on validation-related issues and site systems/equipment assisting in audits and inspections
- To champion validation activities and training material and carry out training in validation/qualification
- Ensure the schedule is maintained reports are written on time and related documents are current according to the site master plan
- Author SOPs related to validation activities and where required for projects
- Represent QA validation in cross-functional meetings/projects as needed
- Conduct root cause analysis and deviation resolution for validation exceptions
- Support related activities within validation and compliance as required by the Validation Manager
- Actively participate in departmental improvement programmes
- Conducts all activities in a safe and efficient manner
- Perform otherrelevantadditionalduties as requested bytheQAValidation Manager in line with business needs.
Experience Knowledge & Skills:
- Relevant Pharmaceutical/GMP proven experience
- Previous experience in a validation/CSV role
- Knowledge of GMP legislation
- Experience dealing with regulatory authorities
- Excellent presentational and motivational skills
- Ability to establish effective working relationships and communicate effectively
- Ability to prioritise own workload to deliver personal and teamobjectiveswithin settimeframes
How will you get here
Demonstrate behaviours in line with theThermoFisher Core Competencies and 4i Values.
Takes ownership accepts responsibility for your actions and always make sound decisions with solid communication skills.
Demonstrate an adaptive and flexible work style shown to be effective working across varied types of clients producttypesand front-line team members.
Ensure compliance with cGMP and training requirements are met in line with business need.
Required Experience:
IC
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
